Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
Angiodynamics Inc. is recalling BIOFLO 8F catheters because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a procedural delay due to a dimensional defect rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 582 units of BIOFLO 8F Single Plastic Filled; Valved catheters (UPN H965440220, Cat. No. 44-022). The recall is due to a defect in the snap lock connectors provided within the implantable port kits.
The snap lock connectors may not meet dimensional specifications. This defect prevents the catheter from being inserted into the snap lock connector prior to connection to the port chamber. As a result, the implantation procedure may be delayed.
The affected units were distributed worldwide, including in the United States (CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI) and Canada. Healthcare providers and patients should contact the recalling firm for further instructions.
The recalled product
- Product
- BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 582
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 5478033
- 5482424
Distribution
Part of a larger recall action
This product is one of 5 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)
See all →- ModerateXcela PICC catheter mislabeled with incorrect size designation
FDA (Devices) · 2021-10-06
- SevereAngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28
- HighAngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
- ModerateAngiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27
Same hazard · dimensional defect
See all →- HighMedline ENFit G-tube connectors may leak from dimensional specification failure
FDA (Devices) · 2026-04-08
- HighMedline ENFit G-tube connector kits may leak from dimensional defect
FDA (Devices) · 2026-04-08
- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- ModerateMedline Soft Liner Dimensional Variation May Affect Outer Canister Fit
FDA (Devices) · 2024-08-28
- ModerateMedical Device Liner Recalled for Dimensional Variation Affecting Fit
FDA (Devices) · 2024-08-28